Lipanthil 200m

Package leaflet: Information for the patient

Lipanthyl 200M, 200 mg, capsules
Fenofibrate
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Leaflet contents

1. What Lipanthyl 200M is and what it is used for
2. Important information before taking Lipanthyl 200M
3. How to take Lipanthyl 200M
4. Possible side effects
5. How to store Lipanthyl 200M
6. Contents of the pack and other information

1. What Lipanthyl 200M is and what it is used for

Lipanthyl 200M belongs to a group of medicines generally known as fibrates. These medicines are used to lower the levels of fats (lipids) in the blood. An example of such fats are triglycerides.
Lipanthyl 200M is used in combination with a low-fat diet and other non-medical treatment methods, such as physical exercise and weight loss, aimed at reducing blood fat levels.
In certain cases, Lipanthyl 200M may be used in addition to other medicines (statins, such as simvastatin, atorvastatin, pravastatin, rosuvastatin or fluvastatin), when blood fat levels cannot be controlled with statins alone.

2. Important information before taking Lipanthyl 200M

When not to use Lipanthyl 200M

• if the patient is allergic to fenofibrate or any of the other ingredients of this medicine (listed in section 6)
• if the patient has previously experienced photosensitivity or skin damage (caused by sunlight or UV light) while taking other medicines such as other fibrates or the anti-inflammatory drug ketoprofen
• if the patient has severe liver or kidney disease, or gallbladder disease
• if the patient has pancreatitis (a condition causing abdominal pain) not caused by high levels of certain types of blood lipids

Do not take Lipanthyl 200M if any of the above apply to the patient. If in doubt, consult a doctor or pharmacist before taking Lipanthyl 200M.

Warnings and precautions

Talk to your doctor or pharmacist before starting Lipanthyl 200M if:

• liver or kidney disease is present
• hepatitis is present: symptoms include yellowing of the skin and whites of the eyes (jaundice) and increased liver enzyme activity (confirmed by laboratory tests)
• hypothyroidism (reduced thyroid gland activity) is present

If any of the above warnings apply (or if in doubt), contact your doctor or pharmacist before starting treatment with Lipanthyl 200M.

Effect on muscles

Stop taking the medicine immediately and contact your doctor if unexpected muscle cramps, pain, tenderness, or weakness occur while taking Lipanthyl 200M.

• This medicine may cause muscle disorders, which can be serious.
• These disorders are rare but may include myositis (muscle inflammation) and rhabdomyolysis (muscle breakdown). These may lead to kidney damage or even death. Your doctor may order blood tests to monitor muscle function before and during treatment.

The risk of muscle breakdown may be higher in certain patients. Inform your doctor if:

• the patient is over 70 years old
• kidney disease is present
• thyroid disease is present
• the patient drinks large amounts of alcohol
• the patient or a family member has a history of inherited muscle disorders
• the patient is taking cholesterol-lowering medicines known as statins, such as simvastatin, atorvastatin, pravastatin, rosuvastatin, or fluvastatin
• the patient has previously experienced muscle disorders while taking statins or fibrates such as fenofibrate, bezafibrate, or gemfibrozil

If any of the above apply (or if in doubt), contact your doctor or pharmacist before starting Lipanthyl 200M.

Lipanthyl 200M and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

In particular, inform your doctor or pharmacist if the patient is taking:

• anticoagulant medicines used to thin the blood (e.g. warfarin)
• other medicines used to control blood lipid levels (such as statins or fibrates). Taking a statin together with Lipanthyl 200M may increase the risk of muscle damage
• medicines used in the treatment of diabetes (such as rosiglitazone or pioglitazone)
• cyclosporine (an immunosuppressive medicine)

If any of the above apply (or if in doubt), contact your doctor or pharmacist before starting Lipanthyl 200M.

Lipanthyl 200M with food, drink, and alcohol

It is important to take this medicine with a meal, as it will be less effective if taken on an empty stomach.

Pregnancy, breastfeeding, and fertility

• Do not take Lipanthyl 200M and inform your doctor if you are pregnant, suspect you may be pregnant, or are planning a pregnancy.
• Do not take Lipanthyl 200M while breastfeeding. Consult your doctor or pharmacist before using this medicine.

Driving and using machines

Lipanthyl 200M has no influence on the ability to drive or operate machinery.

Lipanthyl 200M contains lactose (a type of sugar). If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

This medicine contains less than 1 mmol (23 mg) of sodium per capsule; therefore, it is considered "sodium-free".

3. How to take Lipanthyl 200M

This medicine should always be taken as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Your doctor will determine the appropriate dose based on your condition, current treatment, and individual risk factors.

How to take the medicine

• Swallow the capsule whole with a glass of water.
• Do not open or chew the capsule.
• Take the capsule with a meal – absorption of the medicine is poorer when taken on an empty stomach.

How much medicine to take
The recommended daily dose is 1 capsule of 200 mg once daily.

Patients with renal impairment
Your doctor may reduce the dose in patients with kidney problems. If you have such conditions, consult your doctor or pharmacist. Lipanthyl 200M is contraindicated in patients with severe renal impairment (creatinine clearance < 20 ml/min).

Elderly patients
For elderly patients without renal impairment, the recommended adult dose should be used.

Patients with hepatic impairment
Lipanthyl 200M is not recommended in patients with liver impairment due to lack of clinical data in this patient group.

Use in children and adolescents
Lipanthyl 200M is not recommended for use in children and adolescents under 18 years of age.

Taking more Lipanthyl 200M than recommended
If you take more than the recommended dose, or if someone else accidentally takes this medicine, contact your doctor or the nearest hospital emergency department immediately.

Missed dose of Lipanthyl 200M

• If you miss a dose, take the next dose with the following meal.
• Then continue taking your usual dose at the regular time.
• Do not take a double dose to make up for a missed dose. If in doubt, consult your doctor.

Stopping treatment with Lipanthyl 200M
Do not stop treatment without consulting your doctor, unless the medicine causes you discomfort. Elevated cholesterol levels require long-term treatment.
Remember that in addition to taking Lipanthyl 200M, it is equally important to:

• follow a diet low in fat
• perform regular physical exercise

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the following serious adverse effects occur, stop taking Lipanthyl 200M and contact your doctor immediately – prompt treatment may be necessary:

Not common: may occur in up to 1 in 100 patients

• Muscle cramps or muscle pain, tenderness or weakness – these may be symptoms of muscle inflammation or muscle breakdown, which could lead to kidney damage or even death
• Abdominal pain – may be symptoms of pancreatitis
• Chest pain and shortness of breath – may be symptoms of blood clots in the lungs (pulmonary embolism)
• Pain, redness and swelling in the legs – may be symptoms of blood clots in the legs (deep vein thrombosis)

Rare: may occur in up to 1 in 1000 patients

• Allergic reaction, symptoms may include swelling of the face, lips, tongue or throat, which may cause difficulty breathing
• Yellowing of the skin and whites of the eyes (jaundice) or increased liver enzymes – may be symptoms of liver inflammation

Frequency not known: frequency cannot be estimated from the available data

• Severe skin rash with redness, peeling and swelling of the skin resembling severe burns
• Chronic lung disease

If any of the above-mentioned adverse effects occur, stop taking Lipanthyl 200M and contact your doctor immediately.

Other adverse effects
If any of the following adverse effects occur, contact your doctor or pharmacist:

Common: may occur in up to 1 in 10 patients

• Diarrhea
• Abdominal pain
• Bloating with flatulence
• Nausea
• Vomiting
• Increased liver enzyme activity in blood – detected in laboratory tests
• Increased homocysteine levels in blood (elevated levels of this amino acid in blood are associated with increased risk of coronary heart disease, stroke and peripheral vascular disease, although a causal relationship has not been established)

Not common: may occur in up to 1 in 100 patients

• Headache
• Gallstones
• Decreased libido
• Rash, itching or hives
• Increased creatinine excretion by the kidneys – detected in laboratory tests

Rare: may occur in up to 1 in 1000 patients

• Hair loss
• Increased urea excretion by the kidneys – detected in laboratory tests
• Increased skin sensitivity to sunlight, sunlamps and tanning beds
• Decreased hemoglobin concentration (the pigment carrying oxygen in blood) and decreased white blood cell count – detected in laboratory tests

Frequency not known: frequency cannot be estimated from the available data

• Muscle breakdown
• Complications related to gallstones
• Feeling of fatigue

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181 C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Lipanthyl 200M

Keep this medicine out of the sight and reach of children.
Store in the original packaging at a temperature not exceeding 25°C.
Do not use this medicine after the expiry date stated on the carton after: Expiry
date. The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via the sewage system or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures help protect
the environment.

6. Contents of the pack and other information

What Lipanthyl 200M contains

• The active substance is 200 mg of micronized fenofibrate.
• The other ingredients are: lactose monohydrate, pregelatinized starch, sodium lauryl sulfate, crospovidone, magnesium stearate. Capsule shell composition: titanium dioxide (E 171), red iron oxide (E 172), yellow iron oxide (E 172), gelatin.

What Lipanthyl 200M looks like and contents of the pack
Lipanthyl 200M is available in the form of capsules.
The pack contains 30 capsules.
Marketing Authorisation Holder
Viatris Healthcare Sp. z o.o.
ul. Postępu 21B
02-676 Warszawa
Manufacturer
Recipharm Fontaine
Rue des Pres Potets
21121 Fontaine les Dijon
France
Delpharm L’Aigle
Zone Industrielle No. 1
Route de Crulai
61300 L’Aigle
France
For further information, contact the Marketing Authorisation Holder:
Viatris Healthcare Sp. z o.o.
ul. Postępu 21B
02-676 Warszawa
tel. 22 546 64 00